QA Specialist (Validation)
The Osborne Tech and Eng team is very pleased to be working with our client, a global leader in the manufacturing of medicated feed additives, advanced nutrition solutions, vaccines, and specialty chemicals for a diverse range of industrial markets.
They are committed to the highest standards of quality and compliance to deliver safe, effective products worldwide.
Position Summary:
The QA Specialist (Validation) will play a critical role within the Quality Assurance team, based at the company's Sligo site.
This individual will be responsible for overseeing and ensuring the validation of processes, equipment, and utilities to meet GMP and regulatory standards.
The role involves reviewing and approving validation documentation and supporting the qualification of facilities and equipment to ensure they are fit for ongoing manufacturing operations.
Key Responsibilities:
* Serve as a primary Quality Assurance contact for technical expertise, guidance, and feedback on compliance issues, including validation strategies, new product introductions, and manufacturing processes.
* Review, approve, and oversee validation documentation related to the qualification of facilities, equipment, and utilities to support both startup and ongoing manufacturing operations.
* Manage areas within the Quality Management System (QMS) to ensure product manufacturing is in compliance with GMP and regulatory requirements.
* Generate, review, and approve SOPs and other relevant documentation to ensure compliance with GMP and regulatory standards.
* Ensure that schedules for reviewing and approving GMP/validation documents are aligned with technology transfer timelines and new product introduction projects.
Qualifications & Experience:
* A third-level qualification in a relevant science or engineering discipline.
* A minimum of 5 years of experience working in a GMP-compliant Quality Assurance environment, with a strong focus on validation and qualification activities.
Estimated Salary: $120,000 - $150,000 per year
Job Type: Full-time